Table 4.
Adverse events and adverse drug reactions
| Adverse events | Adverse drug reactions | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Monotherapy (n = 83) | SU concomitant (n = 86) | Total (n = 169) | Monotherapy (n = 83) | SU concomitant (n = 86) | Total (n = 169) | |||||||
| Adverse events or adverse drug reactions | 76 | (91.6) | 78 | (90.7) | 154 | (91.1) | 54 | (65.1) | 60 | (69.8) | 114 | (67.5) |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
| Serious events | 7 | (8.4) | 3 | (3.5) | 10 | (5.9) | 0 | 0 | 0 | |||
| Gastrointestinal symptomsa | 53 | (63.9) | 51 | (59.3) | 104 | (61.5) | 49 | (59.0) | 49 | (57.0) | 98 | (58.0) |
| Hypoglycemia symptomsb | 0 | 19 | (22.1) | 19 | (11.2) | 0 | 16 | (18.6) | 16 | (9.5) | ||
| Blood lactic acid increased | 3 | (3.6) | 0 | 3 | (1.8) | 1 | (1.2) | 0 | 1 | (0.6) | ||
| Lactic acidosis | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
| Common adverse drug reactions (occurring ≥5% of patients in any therapy) | ||||||||||||
| Diarrhea | 48 | (57.8) | 48 | (55.8) | 96 | (56.8) | 46 | (55.4) | 46 | (53.5) | 92 | (54.4) |
| Nausea | 15 | (18.1) | 12 | (14.0) | 27 | (16.0) | 14 | (16.9) | 12 | (14.0) | 26 | (15.4) |
| Abdominal pain | 10 | (12.0) | 9 | (10.5) | 19 | (11.2) | 8 | (9.6) | 9 | (10.5) | 17 | (10.1) |
| Abdominal discomfort | 7 | (8.4) | 10 | (11.6) | 17 | (10.1) | 6 | (7.2) | 9 | (10.5) | 15 | (8.9) |
| Vomiting | 7 | (8.4) | 9 | (10.5) | 16 | (9.5) | 6 | (7.2) | 6 | (7.0) | 12 | (7.1) |
| Anorexia | 9 | (10.8) | 18 | (20.9) | 27 | (16.0) | 8 | (9.6) | 17 | (19.8) | 25 | (14.8) |
| Hypoglycemia | 0 | 13 | (15.1) | 13 | (7.7) | 0 | 10 | (11.6) | 10 | (5.9) | ||
MedDRA/J Ver.10.1
Data are mean ± standard deviation or n (%)
aDiarrhea, nausea, vomiting, abdominal pain and anorexia are defined as gastrointestinal symptoms
bHypoglycemia symptoms include hypoglycemia and hypoglycemia-related symptoms, e.g., excessively hungry with sweating, palpitation, tachycardia, yawning or twilight state